INUMI Flex Needle— 510(k) K233884
Substantially EquivalentGalvanize Therapeutics, Inc.
FDA 510(k) clearance K233884 for INUMI Flex Needle, Substantially Equivalent on 2024-05-22. Applicant: Galvanize Therapeutics, Inc.. Device class: 2.
Clearance details
- Applicant
- Galvanize Therapeutics, Inc.
- Product code
- Code OAB
- Device class
- Class 2
- Regulation
- 21 CFR 878.4400
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Redwood City, CA, US
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More clearances from Galvanize Therapeutics, Inc.
view allAdverse events under product code OAB
product code OAB- Death
- 5
- Total
- 5
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.